Singapore HSA registration DE0510278
Siemens Atellica IM TSH3-Ultra II (TSH3ULII)
Singapore·CLASS B IVD·Siemens Healthcare Diagnostics Inc·Registered January 23, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510278
- Registration Date
- January 23, 2025
- Retention Due Date
- January 22, 2026
Product description
The Atellica® IM TSH3‑Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Product Owner
- Short Name
- Siemens Healthcare, USA
- Address
- 511 Benedict Avenue, Tarrytown, NY 10591, UNITED STATES
Registrant
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Importer
- Address
- 60 MACPHERSON ROAD, THE SIEMENS CENTRE, SINGAPORE 348615
Model information
- Model Name(s)
- Atellica IM Multi‑Diluent 15 Atellica IM TSH3-Ultra II (TSH3ULII) Atellica IM TSH3-Ultra II (TSH3ULII) Atellica IM TSH3ULII Master Curve Material (TSH3ULII MCM)
- Model Identifier(s)
- 11200798 11208706 11208707 11208876
About this record
Access comprehensive regulatory information for Siemens Atellica IM TSH3-Ultra II (TSH3ULII) in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510278 and owned by Siemens Healthcare Diagnostics Inc. The device was registered on January 23, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD